Cleared Traditional

HBA1C CONTROL, LEVEL 1 AND LEVEL 2

K131999 · Randox Laboratories, Ltd. · Chemistry
Jul 2013
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K131999 is an FDA 510(k) clearance for the HBA1C CONTROL, LEVEL 1 AND LEVEL 2, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on July 26, 2013, 28 days after receiving the submission on June 28, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K131999 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2013
Decision Date July 26, 2013
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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